FDA Approves New Manufacturing Facility for Collagenase SANTYL® Ointment

Immediately Doubles Manufacturing Capacity

Dec 08, 2010, 10:46 ET from Healthpoint

FORT WORTH, Texas, Dec. 8, 2010 /PRNewswire/ -- Healthpoint today announced that the U.S. Food and Drug Administration has granted approval to manufacture commercial supplies of Collagenase SANTYL® Ointment, a biologic enzymatic debriding agent, at DPT Laboratories' Center of Excellence for Sterile & Specialty Products facility in Lakewood, New Jersey. DPT Laboratories is one of Healthpoint's contract manufacturers for the brand.

"The approval of this second production facility marks a significant milestone for the SANTYL® brand, allowing us to immediately double our manufacturing capacity for this important therapeutic agent," said Travis E. Baugh, President and Chief Operating Officer of Healthpoint. "The approval culminates a multi-year effort undertaken to ensure continuous, uninterrupted supply to the healthcare community of the only FDA-approved enzymatic debrider available in the United States."

About Collagenase SANTYL® Ointment

Collagenase SANTYL® Ointment is a selective enzymatic debriding agent that contains 250 collagenase units per gram of white petrolatum USP. It is indicated for debriding chronic dermal ulcers and severely burned areas.* The enzyme collagenase is derived from the fermentation by Clostridium histolyticum and possesses the ability to liquefy collagen in necrotic tissue.

*Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound. One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone. See complete prescribing information online at: http://www.santyl.com/prescribing.

About DPT Laboratories

DPT, a DFB Pharmaceuticals, Inc. affiliate company, is a contract development and manufacturing organization (CDMO) providing companies the best solutions to their sterile and non-sterile drug development and manufacturing needs through innovation, technology and service. Specializing in semi-solid and liquid dosage forms, DPT has a reputation for quality, unmatched technical expertise, extensive manufacturing capabilities and an exemplary regulatory compliance record. With five cGMP facilities, including R&D, manufacturing and packaging operations in San Antonio, Texas, and Lakewood, New Jersey, DPT offers full service outsourcing solutions. For more information, call 210-476-8100 or visit www.DPTLabs.com.

About HEALTHPOINT, Ltd.

Since 1992, HEALTHPOINT has been dedicated to innovative technologies for the prevention and treatment of acute, chronic and burn-related wounds. The company is presently focused on the research and development of novel biologics and pharmaceuticals intended to improve clinical and quality of life outcomes. Currently marketed products include: Collagenase SANTYL® Ointment, OASIS® Wound Matrix and HYDROFERA BLUE® Bacteriostatic Wound Dressings. HEALTHPOINT is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from THE WOUND INSTITUTE®. To learn more about this comprehensive and award winning educational resource, please visit TheWoundInstitute.com®. HEALTHPOINT is a DFB Pharmaceuticals, Inc. affiliate company, and is based in Fort Worth, Texas. For more information, visit the HEALTHPOINT website at www.healthpoint.com.

Healthpoint and design, SANTYL, THE WOUND INSTITUTE and THEWOUNDINSTITUTE.COM are registered trademarks of Healthpoint, Ltd.

OASIS is a registered trademark of Cook Biotech, Inc.

HYDROFERA BLUE is a registered trademark of Hydrofera, LLC.

SOURCE Healthpoint



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